3
ENGLISH
WEEE Product disposal symbol
Caution
CE marking
Lot number
Serial Number
Consult instructions for use
Alternating Current
Protective earth (ground)
Warning – dangerous voltage (black on yellow)
Expiry Date
Standby
LAN
Local area network, Ethernet connector (RJ45)
Refer to instruction manual / booklet .
Follow instructions for use (blue on white )
Warning- Possibly hazardous optical radiation emitted from
this product (black on yellow) . Do not stare at operating
lamp . May be harmful to the eyes . The present system
is in risk group 2
The calibration patches must not be touched and
must not be exposed to liquids (red on white)
Mass of the TRIOS System, incl . safe working load
(in kilograms)
The product contains an RF transmitter
RFID tag
Electrical insulation Class II
Medical Device
Global Trade Item Number
Prescription Only (applicable for United States of America)
Model Number
4. Description of TRIOS
4.1 Certification and Compliance Notes
CE marking
This product bears CE marking in accordance with the provisions of Medical
Device Regulation (EU) 2017/745, Registration, Evaluation, Authorization and
Restriction of Chemicals Regulation 1907/2006/EC, Restriction of Hazardous
Substances in Electrical and Electronic Equipment Directive 2011/65/EU, Waste
Electrical and Electronic Equipment Directive 2012/19/EU, Radio Equipment
Directive 2014/53/EU .
CAUTION – EU only
CE marking for connected products
Further products which are connected to this unit
must also bear the CE marking .
IMPORTANT NOTICE
To comply with the CE marking of the integrated wireless
module, the wireless scanner must only be used indoors .
Electrical Safety
This system has been tested to conform with the EN (IEC) 60601-1
Safety Standard for medical electrical devices with a Patient applied part (the
standard title is: Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance), EN (IEC) 60601-1-2 Medical electrical
equipment Part 1-2 General requirements for basic safety and essential perfor-
mance - Collateral Standard: Electromagnetic disturbances - Requirements
and tests, and EN (IEC) 62471 Photobiological safety of lamps .
The system has also been tested to conform with CAN/CSA-C22 .2 No .
60601-1:14 and ANSI/AAMI ES60601-1 +C1(2009) + A1 (2012) + A2 (2010) .
WARNING
Any person who assembles or modifies a medical electrical
equipment or system complying with the standard EN (IEC)
60601-1 (safety requirements for medical electrical equip-
ment) by combining it with other equipment is responsible
for conducting appropriate inspection and testing to ensure
continued safe use of the equipment and for ensuring that
the requirements of this regulation are met to their full
extent for the safety of the patients, the operators and
the environment .
